Concept Endpoints Informing Design Considerations for Confirmatory Clinical Trials in Osteoarthritis

2020 ◽  
Author(s):  
Yura Kim ◽  
Gregory Levin ◽  
Nikolay P. Nikolov ◽  
Robert Abugov ◽  
Rebecca Rothwell
Author(s):  
Paula P. Schnurr ◽  
Jessica L. Hamblen

This chapter provides an overview of key concepts in designing and evaluating clinical trials, with a focus on randomized controlled trials for PTSD. The first section discusses design elements and how they influence the conclusions that can be drawn from a study. Examples from the trauma literature are provided when available to illustrate concepts. The second section explores newer developments in PTSD treatment trials. Specifically, it discusses treatment and design considerations related to common comorbid conditions of PTSD, adapting treatments for low-resource environments and optimizing treatment outcome. The chapter’s goal is to improve the ability of both clinicians and researchers to critically review PTSD clinical trials.


Pain ◽  
2015 ◽  
Vol 156 (7) ◽  
pp. 1184-1197 ◽  
Author(s):  
Jennifer S. Gewandter ◽  
Robert H. Dworkin ◽  
Dennis C. Turk ◽  
John T. Farrar ◽  
Roger B. Fillingim ◽  
...  

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